A Medical Device Daily

Consumers Union (Washington) has filed a petition with the FDA requesting it require all advertisements for implantable devices — such as knee, hip and heart valve replacements, cosmetic implants and heart stents — carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.

Implantable device makers recently have launched a wave of direct-to-consumer (DTC) advertisements for their products, and Consumers Union said a review of these ads shows that most lack basic information about the possibility of severe or fatal side effects.

“There is no question that many of these devices can restore high quality of life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

Peake new VA secretary

James Peake has been sworn in as secretary of the U.S. Department of Veterans Affairs after being confirmed by the Senate Dec. 14.

Peake said he would focus on smoothing the transition from military to veterans’ healthcare and improve benefits for wounded service members.

He said that the recommendations of a presidential committee led by former Sen. Bob Dole (R-Kansas) and Donna Shalala, former secretary of the Department of Health and Human Services, offered “a powerful blueprint to move forward.”

Peake graduated from West Point in 1966. As a second lieutenant he served in Viet Nam with the 101st Airborne. As a platoon leader, he led men in combat, and earned several medals, including the Silver Star and two Purple Hearts.

While in the hospital recovering from his second wound, he learned that he had been accepted to medical school.

After completing his medical studies at Cornell University (Ithaca, New York), he worked as an Army doctor to improve care for wounded soldiers and developed new ways of delivery medical care to them.

After his Army service, Peake served as executive VP and chief operating officer of Project Hope. There he helped one Navy hospital ship respond to the victims of the Asian tsunami and another that was sent to care for those hit by Hurricane Katrina.

Most recently, he has served as chief medical director and chief operating officer with QTC Management, which provides military veterans with medical examinations, as well as electronic medical record services.

In nominating Peake, President George Bush said, “As a medical officer and combat vet who was wounded in action, Dr. Peake understands the view from both sides of the hospital bed — the doctor’s, and the patient’s. He brought that understanding to many jobs. These jobs include command surgeon in the Army hospitals, commanding general of the largest medical training facility in the world, and Army Surgeon General — where he commanded more than 50,000 medical personnel, oversaw 16 hospitals across the world and managed an operating budget of nearly $5 billion.”

“When confirmed by the Senate, Dr. Peake will bring his unique set of skills and experiences to the Department of Veterans Affairs. He will be the first physician and the first general to serve as Secretary. He will apply his decades of expertise in combat medicine and health care management to improve the veterans’ health system. He will insist on the highest level of care for every American veteran.

President Bush said that one of Peake’s first tasks as secretary of the VA will be to continue to implement the recommendations of the Dole-Shalala Commission on Wounded Warriors ... Some of their recommendations are the responsibility of the executive branch, and Dr. Peake will be a leader in carrying them out. Others require the approval of United States Congress, and that’s why this month I sent a bill to Capitol Hill that will make those recommendations the law of the land.”

FDLI event focuses on regulation, policy

Food and Drug Law Institute (Washington) reported that it will hold its 1st Annual Conference on Nanotechnology Law, Regulation and Policy, Feb. 28-29, at the L’Enfant Plaza Hotel, in Washington,

The organization said that at the conference “ food and drug industry representatives will find out what’s happening internationally on nanotech regulation, how venture capitalists look at the future of nanotechnology and what the leading corporations, scientific laboratories and academic centers are focusing on in this dynamic field.”

The conference, co-sponsored by the Project on Emerging Nanotechnologies of the Woodrow Wilson International Center for Scholars (Washington), in partnership with Arizona State University (Tempe) and the Burdock Group, will address the crucial issues surrounding nanotechnology law, regulation and policy.

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